APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
FDA Recall Z-0150-2015 · Posted 2014-10-30
Recalling FirmMedartis, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2014-10-01
Date Terminated2015-08-06
Product Quantity44
Reason for Recall
A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
Firm Action
The recall is being extended to end user level of distribution. The sales representatives, customers and a distributor were notified via phone or email on September 19th and notified of the recall via US mail on 10/1/14. US customers, distributors, and sales representatives were instructed to return the affected instrument kits to the importer Medartis, Inc. via transport agency.
Root Cause
Process design
Distribution Pattern
US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.